A clean room environment is a room designed, maintained, and controlled to prevent particle and microbiological contamination from entering or residing in products that will be manufactured in the controlled environment. There are different levels of cleanliness in clean rooms, generally in the range of a ISO 5, Grade A, Class 100 room (i.e., a room having 100 particles of 0.5 micron and larger, per cubic foot of air), to a ISO 8, Grade D, Class 100,000 clean room. Clean rooms are used for a variety of purposes, including to manufacture pharmaceutical products and electronics, such as semiconductors. Clean rooms have to maintain a high level of cleanliness, or risk large financial losses. If a product being developed or manufactured in a clean room becomes contaminated, the entire product in the clean room must often be discarded.
The U.S. Food and Drug Administration (“FDA”) requires firms to assure that every element of the manufacturing environment and manufacturing process are proven to be acceptable to FDA requirements and industry standards. The FDA requires firms to operate in accordance with Current Good Manufacturing Practices (CGMP). To do this, firms are required to assure that products, personnel, training, ingredients, procedures and systems used in the manufacture of a drug product have undergone stringent testing. In light of the strict standards that clean rooms must satisfy, companies are very reluctant to introduce new products into their clean rooms that have not been extensively tested and proven reliable.
It would not be acceptable if the manufacturing method resulted in a product that might contaminate a clean room. Certain chemicals are used inside a clean room to disinfect the clean room. However, some chemicals can lose effectiveness or become unstable after a short period of time (e.g., 20-30 days) once the chemical is mixed or when the chemical is saturated onto a wipe. Consequently, those chemical compositions need to be diluted just prior to use or introduced onto a wipe just prior to use. Yet, it is particularly difficult and time-consuming to dilute chemical compositions and/or to saturate a wipe inside a clean room because of possible contamination of the chemicals by the environment and because the user is outfitted in sterile garments and gloves.
Controlled or clean environments, such as hoods, clean rooms or facilities have strict requirements for cleanliness, particularly requiring surfaces to be cleaned often and on a consistent basis. Conventional packaged saturated wipes may be not sufficiently sterile for a clean room or are easily contaminated because of design of the package and/or because the chemical interacts with the structure of the wipe or other chemicals on the wipe. Also the wipes in conventional packages often deteriorate or lose the potency of the active ingredient(s) of the cleaning agent. Additionally, some cleaners are mixed with water just prior to use inside clean room, which is time-consuming and labor-intensive. Cleaners also have a short shelf life after mixing; and the exact amount of water to cleaner must be precisely measured. Many sanitizers, disinfectants and sporicides used in saturated wipes have the inability to be mixed with water for extended time periods. This stability problem relates to the degradation of the active ingredients over time in the solution and is further complicated by the presence of the wiping material, wiping material additives and air in the package.
Examples of conventional wipes containers include U.S. Pat. Nos. 8,038,000; 7,850,041; 7,681,725; 7,357,248; 6,866,145; 6,827,080; 6,001,187; 5,988,371; and 5,814,159, the subject matter of each of which is herein incorporated by reference.
Therefore, a need exists for a sterile wipe container that reduces deterioration of the wipes and associated cleaning agent.